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Senior/Team Lead International Regulatory Affairs Specialist

vor 2 Monaten


Munich, Bayern, Deutschland Vality One Recruitment GmbH Vollzeit
About the Role

We are seeking a highly experienced Senior/Team Lead International Regulatory Affairs Specialist to join our team at Vality One Recruitment GmbH.

Key Responsibilities
  • Oversee all approval processes, including life cycle management, in approximately 35 countries worldwide.
  • Lead and develop a 12-strong team, fostering a collaborative and productive work environment.
  • Develop and implement a comprehensive approval strategy for the region, ensuring timely completion of tasks through effective prioritization.
  • Serve as the primary point of contact for Business Development and Market Access, driving overarching goals and decision-making.
  • Cultivate strong relationships with authorities, including occasional on-site presence, to ensure seamless approval processes.
  • Coordinate closely with internal stakeholders as part of the approval process.
Requirements
  • Hold a degree from a reputable scientific institution.
  • Possess relevant experience in international marketing authorization of medicinal products.
  • Initial management experience is desirable, but can be developed on the job.
  • Demonstrate strong analytical and forward-thinking skills.
  • Fluency in English is essential, with good knowledge of German and ideally French.
  • Be willing to travel globally, approximately once a month.
What We Offer
  • A wide range of development opportunities to enhance your skills and career.
  • A comprehensive benefits package, including fitness allowances and more.